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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vinyl patient examination glove
510(k) Number K120584
Device Name POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
Applicant
WEALTH ON (JIANGSU) CO., LTD
5 CAREY ST
PENNINGTON,  NJ  08534
Applicant Contact CHARLES SHEN
Correspondent
WEALTH ON (JIANGSU) CO., LTD
5 CAREY ST
PENNINGTON,  NJ  08534
Correspondent Contact CHARLES SHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/27/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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